Amanda Pack is a Staff Engineer, Lead Auditor and Lead Regional Lead Reviewer for Underwriters Laboratories (UL).
In Ms. Pack’s 15 + years at UL, she has held positions working with manufacturers of medical and IVD devices, including reviewing and assessing medical devices for conformity to UL and International safety standards, assessing technical files for Notified Body approvals, and auditing medical manufacturers’ quality systems to internationally accepted requirements.
Amanda holds international experience as a Lead CMDCAS accredited auditor, Notified Body auditor for the IVD Directive and Medical Device Directives and Japan PAL qualified auditor.
Amanda is also qualified as an ISO 17025 auditor under the CB Scheme. Ms. Pack has years of experience assessing product technical files to international regulatory requirements under the Medical Device Directive and is qualified under the FDA 510(k) Third Party Review program. In addition to her technical experience, Amanda has presented at several medical industry events and is a qualified trainer for UL University technical external training program.
Amanda holds a Bachelor of Science in Biological Systems Engineering from University of California, Davis, with a specialization in Biomedical/Biotechnical Engineering.